labsolutions

KRUUSE Borrelia Quick
The Test Cassette
Rapid test for detection of Borrelia antibodies in whole blood, serum or
plasma.
Instruction Manual
The test strip is located behind the plastic cover. The sample well is on the
right side. The reaction field is located in the middle of the test cassette. The
test and the control region are located in the reaction field. The labelling next
to the reaction field shows the test and control region.
KRUUSE Borrelia Quick, the rapid test for the detection of Borrelia antibodies
in whole blood, serum and plasma.
Sample well
for blood sample
Canine Lyme Disease
Lyme disease is one of the diseases transmitted by vectors (ticks). The pathogen
Borrelia burgdorferi is a gram-negative, spiral-shaped and movable bacterium
(spirochete). Worldwide, at least 13 genospecies belong to the Borrelia
burgdorferi sensu lato (Bsl) complex. The three most important species B.
burgdorferi sensu stricto (Bss), B. garinii (Bg) and B. afzellii (Ba) are also
pathogenic for humans. For dogs, the pathogenicity of B. burgdorferi sensu
stricto has been verified.
The natural reservoir for Borrelia is wild animals. Borrelia is transmitted by ticks
of the species Ixodes ricinus. An infection does not always lead to immediate
illness, it may take a long time (2-5 months) before clinical symptoms occur.
cClinical signs of the disease in dogs often develop insidiously and can be
nonspecific symptoms such as lethargy, lymphadenopathy and intermittent
fever. A possible clinical manifestation is infection-related arthritis in one or
more joints, sometimes with shifting leg lameness. Occasionally glomerulopathies
occur. Even with effective antibiotic therapy a complete elimination of the
pathogens is difficult.
Explanation of the Testing Process
KRUUSE Borrelia Quick rapid assay is a sandwich immunoassay which is developed
for professional use by veterinarians. The gold-labeled immunoglobulin
complexes are transported by capillary action with the fluid across the membrane
and bind to immobilized antigens in the test region of the test strip.
With a positive test result, i.e. with the presence of specific antibodies against
the Borrelia antigen, an aggregate builds in the test region consisting of
antigen, anti-Borrelia antigen-antibody and the gold-labeled detection
antibody and thus forms a colored line. If no colored line shows in the test
region, the test result is negative. In both cases, a coloured line in the control
region is visible. This indicates correct testing process of the KRUUSE Borrelia
Quick.
Upon application to the test strip Borrelia antibodies in the sample material
react with the gold labelled antigens in the conjugate pad. The fluid then
migrates up the strip by capillary action. In the test line region the Borrelia
antigen-antibody gold marked complexes are captured by the immobilised
capture reagents so that a red line is generated. The presence of a red line in
the test line region indicates a positive result. If the sample does not contain
Borrelia antibodies, no line will form in the test line region. Additionally, a red
line must form in the control line region, independently of the presence of
Borrelia antibodies in the specimen.
The control line serves as an internal control and indicates that sufficient
sample fluid has been applied to the test strip and that proper wicking of the
membrane has occurred.
Reaction field
test and control region
CAUTION
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Only for veterinary and professional use
For single use only
Use the test cassette within 10 minutes of opening
Please use an appropriate amount of sample
Do not apply sample solution to the reaction field
Avoid cross reactions by using a new sample tube for each sample
Do not touch the reaction field
Use only the original buffer provided in the kit
Sample material could be infectious. Be careful with waste disposal
Do not use cassettes after the expiry date
Do not use the test if the packaging is damaged
Consider the test results as invalid after the indicated time
Reagents, Materials, Instruments
I. Contents
• 5 test cassettes with pipette and drying pad
• 5 sample tubes
• 1 bottle with 2.5 ml reagent buffer
• 1 instruction manual
II. Additional Necessary Equipment
•Timer
Sample Preparation
KRUUSE Borrelia Quick was developed for examination of whole blood, serum
or plasma.
General recommendations for blood samples
• Separate serum or plasma from blood as soon as possible to avoid
haemolysis
• Heparin or EDTA blood can be used for the plasma extraction
• Use only clear, non-haemolyzed specimens
• Use of whole blood my decrease the sensitivity of the test result
Testing should be performed immediately after sample collection. Do not
leave the specimens at room temperature for prolonged periods. Serum and
plasma specimens may be stored at 2-8° C for up to 3 days. For long-term
storage, specimens should be kept below -20°C. Whole blood collected by
venipuncture should be stored at 2-8°C if the test is to be run within 2 days of
collection. Do not freeze whole blood specimens. Bring specimens to room
temperature prior to testing.
Frozen specimens must be completely thawed and mixed well prior to
testing. Specimens should not be frozen and thawed repeatedly. If specimens
are to be shipped, they should be packed in compliance with local
transportation regulations for etiologic agents.
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Test Procedure for Serum and Plasma
Positive Result
1.
The test is positive when the control line (C) and the test line (T) are
visible in the reaction field.
Antibodies against Borrelia antigen are detected in the sample
material.
If a faint test line appears, the test result is still positive.
The red colour in the test region will vary depending on the
concentration of Borrelia antibodies present in the sample material.
Take a blood sample and prepare the serum or plasma sample. Open the pouch; remove the pipette and pick up the sample material with the pipette.
Apply one drop of serum or plasma with the pipette into the sample well. Wait a few seconds until the sample fluid is completely absorbed.
2. Open the buffer and add 2 drops of the buffer into the sample well.
If the liquid is not running well up the strip after 1,5 minute, add an
additional drop of buffer into the sample well.
Attention: It is possible with KRUUSE Borrelia Quick to
distinguish between natural exposure and vaccination
antibodies. A serological test for antibodies against Borrelia
should always be interpreted in relation with the clinical
symptoms.
3. Read the results within 5-10 minutes of starting the test.
1.
2.
Test Procedure for Whole Blood
1.
Take a blood sample. Open the pouch; remove the pipette and pick up the
sample material with the pipette and place 1 drop of the whole blood into the sample tube.
Open the buffer and add 3 drops of the buffer into the sample tube
2.
Close the sample tube and shake it gently. Open the sample tube again and pick up the sample material with the pipette. Slowly apply 2 drops of the sample
material with the pipette into the sample well (add the first drop to the sample well, wait a few seconds until the drop is absorbed, then add the second drop)
If the liquid is not running well up the strip after 1,5 minute, add an
additional drop of buffer into the sample well.
Negative Result
The test is negative when only the control line (C) is visible.
The test is negative when only a control line appears in the reaction field and there is no weakly defined test line visible. No Borrelia
antibodies were detected in the sample material.
Invalid Result
If no control line is visible after the test was performed, the test is invalid. In this
case, the test might not have been correctly carried out, the test may have passed
the expiry date or the test was exposed for too long to ambient air outside the
sealed pouch. If this occurs, a new test must be conducted.
ATTENTION: The result must be read within 10 minutes of starting the
test. The test and the result are considered as invalid after that period.
3. Read the result within 5-10 minutes of starting the test.
Remarks: The test result should always be judged in connection with the
anamnestic response and clinical context. All test results obtained with whole blood
samples, which do not correlate with the clinical picture, should be repeated with a
plasma or serum sample, as test of whole blood may decrease the sensitivity of the
test result.
1.
Storage
KRUUSE Borrelia Quick must be stored at room temperature (2°C to 30°C).
2.
Disposal
A safe disposal is recommended. Sample material and test cassettes should be
collected in a sealable plastic bag.
Test Evaluation
Test Performance Characteristics
The results of the test can be read 5-10 minutes after starting the test.
KRUUSE Borrelia Quick
IgG ELISA, IgM ELISA, ImmunoBlot
Sensitivity
Note: A detection of antibodies in the sample material is not possible
until 3-4 weeks after infection.
Borrelia antibodies
Specificity
95,83 %
94,12 %
References
1) R. K. Straubinger, N. Pantchev (2010): „Die Lyme-Borelliose-Impfung beim
Hund-kontrovers diskutiert“, Kleintier Konkret, Enke Verlag, Stuttgart, 5:8-11.
2) H. J. Selbitz, U. Tryen, P.V. Weigand (2010): „Medizinische Mikrobiologie,
Infektions- und Seuchenlehre“, 9. Aufl. Enke Verlag, Stuttgart.
3) Gary P. Worms and Ira Schwartz (2009): “Antibiotica Treatment of animals infected with Borrelia burgdorferi”, Clinical microbiology reviews, July 2009,
387-395.
Symbols Used
Only for one use
labsolutions
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Content
+30°C
Storage temperature
+4°C
Lot number
www.kruuse.com
Read user instruction carefully
Expiry date